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Policies & Legislation

New stability testing rules for generics

Both EMA and FDA are increasing their requirements for stability testing, especially for generic drugs. These changes could significantly increase the length of time required to gain regulatory approval and increase costs for generics manufacturers to get their drugs onto the market.

Australia and New Zealand outline plans for joint regulatory agency

The Australian and New Zealand governments have agreed to proceed with a joint scheme for regulation of therapeutic goods, i.e. medicines, medical devices, etc. The creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries.

Practical guidance on new pharmacovigilance legislation

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is the regulatory body responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation will be effective from July 2012.

China cuts drug prices for the second time in 2011

China has, for the second time this year, cut the price of drugs. The maximum retail price of 82 different pharmaceutical drug types has been lowered by an average 14% in a move to reduce patient’s medical bills.

US President approves patent reform

On 16 September 2011, US President Barack Obama signed into law a patent-reform bill that has been backed by brand-name drugmakers but opposed by generics companies.

US Senate approves patent reform

On 8 September 2011, the US Senate passed a patent-reform bill that has been backed by brand-name drugmakers but opposed by generic companies.

European Commission publishes new rules on falsified medicines

A new directive on falsified medicines was published in the Official Journal of the European Union 1 July 2011.

Effect of patent filing and initiation of clinical trials on market exclusivity

The effect of the date of patent filing and the initiation of clinical trials can influence the expected duration of marketing exclusivity for originator companies.

Concerns of patent filing and approval date on market exclusivity

An understanding of the relationship between the date of patent filing and the marketing approval date on the expected duration of marketing exclusivity is critical for originator companies to maximise this period of exclusivity in order to recuperate their research and development costs before the advent of generic competition. Recent research has modelled the available duration of US market exclusivity for originator drugs at various times after the initial patent filing [1].

Patent filing and market exclusivity

The relationship between patent filing dates and the marketing authorisation date can change the duration of marketing exclusivity an originator pharmaceutical product can expect to enjoy [1].